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Clinical Trial Summary

The proposed investigation is a multi-center, prospective, randomized, controlled comparison of the BAGUERA®C to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD). Subjects will be randomized in a 2:1 ratio to the one-level BAGUERA®C Cervical Disc Prosthesis (investigational group) or to the one-level Mobi-C® Cervical Disc (control group). Subjects enrolled in the study will be evaluated pre-operatively, at the time of surgery, discharge, and at 6 weeks, 3, 6, 12, and 24 months and then annually until 7 years post-surgery.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04520776
Study type Interventional
Source Spineart USA
Contact
Status Active, not recruiting
Phase N/A
Start date March 2, 2021
Completion date February 2026

See also
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